Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial.
JOP
; 13(5): 514-8, 2012 Sep 10.
Article
in En
| MEDLINE
| ID: mdl-22964958
ABSTRACT
CONTEXT Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis. OBJECTIVE:
Our aim was to assess the efficacy of a neurokinin-1 receptor antagonist (aprepitant) at preventing post-ERCP pancreatitis in high risk patients.DESIGN:
Randomized, double-blind, placebo controlled trial at a single academic medical center. INTERVENTION Patients at high risk for post-ERCP pancreatitis received either placebo or oral aprepitant administered 4 hours prior to ERCP, 80 mg 24 hours after the first dose, and then 80 mg 24 hours after the second dose. PATIENTS Thirty-four patients received aprepitant and 39 patients received placebo. STATISTICS Fisher's exact test was used to compare incidence of post-ERCP pancreatitis in the two groups.RESULTS:
Baseline characteristics were similar between the two groups. Incidence of acute pancreatitis was 7 in the aprepitant group and 7 in the placebo group. Hospitalization within 7 days post-procedure for abdominal pain that did not meet criteria for acute pancreatitis occurred in 6 and 9 patients in the aprepitant and placebo groups respectively (P=0.772).CONCLUSIONS:
Aprepitant did not lower incidence of post-ERCP pancreatitis in this preliminary human study. Larger studies potentially using the recently available intravenous formulation are necessary to conclusively clarify the efficacy of aprepitant in this setting.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pancreatitis
/
Morpholines
/
Cholangiopancreatography, Endoscopic Retrograde
Type of study:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Limits:
Adult
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
JOP
Journal subject:
ENDOCRINOLOGIA
/
GASTROENTEROLOGIA
Year:
2012
Document type:
Article
Affiliation country:
Estados Unidos